European chemical industry to face one of its greatest challenges since decades

SCC’s President Dr Friedbert Pistel shared his standpoints on the future of the European chemical industry with the Chemical Daily in Japan.  - Japanese Version -

Date: 19 December 2016

For almost 10 years, SCC has been running its Liaison Office in Japan, providing assistance and service to Japanese and overseas companies on the Japanese market.

The Chemical Daily interviewed Dr Friedbert Pistel about REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), global regulatory developments, critical issues to be aware of and how these challenges are managed by SCC.
Q1: Dr Pistel, what are the major challenges for the chemical industry in Europe?
Dr F. Pistel: First of all there is just one and a half years left until 31 May 2018 - the third and last deadline for the registration of chemicals in a volume of 1 to 100 tons per year under the European Chemical legislation REACH. The chemical industry, small and medium-sized companies in particular, have to urgently recognize this point. After a successful registration, dossiers should be continuously updated. “No data, No market” is the EU REACH principle. 

A further challenge is the requirement to join the SIEF (Substance Information Exchange Fora) to share data and avoid duplicate animal testing, based on the principle “One Substance, One Registration” requested by ECHA (European Chemical Agency). According to Commission implementing Regulation (EU) 2016/9 of 5 January 2016, the obligations are strengthened to share information and management cost in a fair, transparent and non-discriminatory manner.

Q2: How is improvement of supply chain communication being handled?
Dr F. Pistel: The improvement of communication concerning safe use information up and down the supply chain is currently done with the e-SDS (Extended Safety Data Sheet). Several downstream user sector organisations are working on so called “use maps” in order to prepare more realistic exposure scenarios and to improve the data quality of the safety data sheet. For example, the Annex of the safety data sheet might be replaced by a Sumi (“Safe Use of Mixtures Information”).

Q3: Is it possible that the systems of the EU chemical regulation become a global model?
Dr F. Pistel: I think the European Chemical Regulation REACH has a big model character. Asian countries such as Japan, Korea, China and Thailand have recently introduced their way of chemical risk assessment, and the United States of America is currently reforming the TSCA (Toxic Substance Control Act). REACH has been used as a model for these changes, even if polymers have not been so far handled by the Regulation (EC) No 1907/2006. With other areas requiring polymer registration, we, however, believe the EU will follow suit soon. Among other global scientific challenges are the definition of criteria for endocrine disruptors and the delivery of safe use information for nanomaterials.

Q4: Which implications on EU chemical policy of the forthcoming BREXIT do you expect?
Dr F. Pistel: A letter of resignation by the British government has not been submitted to the EU and nobody is sure at what time it will come. This subject and the future economic status of Great Britain in Europe are yet unclear. It is premature to speculate about implications. However, the British administration is taking a pragmatic approach which affects discussions about risk assessment and management of chemicals as well as plant protection and biocidal products.

Q5: How does SCC support industry in managing current challenges?
Dr F. Pistel: As a regulatory consulting company, SCC has been supporting our global customers with all their registration needs around agrochemicals, chemicals and biocides during our more than 25-year history. Key to our success is our scientific expertise, bundled in the Regulatory Science business unit. We are successfully working with CRO’s around the world and are able to offer not only studies requested, but in addition a scientific monitoring during the whole study period guaranteeing a high quality of data.